Development of a Clinical Trial Strategy
Health Advances helped a large public medical device company develop a clinical trial development plan for cellular therapies in cardiac indications. The client needed to address issues related to clinical trial feasibility, timelines, and cost in order to evaluate potential investment opportunities. The analysis included an extensive investigation of relevant cellular therapy literature, existing trial benchmarks for relevant patient segments, and interviews with cardiovascular and cell therapy experts. Final output included identification of the most promising cell types and delivery mechanisms to move into development, attractive patient target populations, inclusion/exclusion criteria, endpoints for Phase I, II, and II trials, and estimates of trial size based on literature benchmarks.
Formulation of a New Product's Development and Commercialization Plan
Health Advances worked with a large public biotech company to formulate a business strategy for a new product's development and commercialization. First, the team assembled a comprehensive primer on the disease, its segmentation, its presentations and its manifestations. Then, the team recommended primary and secondary endpoints for their clinical trials based on clinician feedback as to which endpoints would capture the largest patient population and what labeling the product could achieve. The work highlighted commercialization activities targeted at each stage of development of the product. Lastly, Health Advances delved into reimbursement issues in the US and in Europe (France, UK and Germany), addressing issues such as office infusions for rheumatologists.
Designing Key Clinical Trial Protocol Inputs
Health Advances was asked to assist a small biotech company in the process of designing key inputs to a clinical trial protocol to understand the appropriate clinical endpoints that should be measured, as well as the importance of capturing pharmacoeconomic and quality of life information. Health Advances characterized the current patient populations, referral patterns, and gathered information regarding diagnosis, evaluation and treatment of patients to help develop the clinical trial strategy. Additionally, information regarding current resource utilization and quality of life issues was summarized into a pharmacoeconomic model.
Evaluation of Clinical Trial Design Options
Health Advances helped a small private biotech company to evaluate various clinical trial design options for its therapeutic vaccine for pancreatic cancer in the US, Canada, and Australia. Specifically, Health Advances: 1) defined disease progression and current standards of care in each of the major pancreatic cancer patient segments, 2) assessed the pros and cons of various trial designs (patients and treatment arms), and 3) estimated the likely accrual rates for the most attractive trial designs.
Regulatory Strategy and Market Assessment in Europe and Japan
Health Advances performed an analysis of the market potential for a pegylated EPO product in Europe and Japan. The study looked at current products on the market as well as those in development. A review of the various regulatory pathways was also examined to identify any major hurdles by country or potential faster track pathways to initiate approval.
Assessment of Regulatory and Reimbursement Requirements in the EU
A commercialization strategy was developed in the UK, France, Germany, Italy and Spain that maximized adoption of an assay predicting patient response to HIV therapy. Health Advances determined regulatory and reimbursement requirements in each country for a diagnostic assay that would be performed in a CLIA approved lab in the US. In addition, shipping and handling logistics and costs were considered under numerous possible scenarios. Health Advances then developed a strategy to provide the greatest opportunity for adoption as well as approval while considering costs.
Application Prioritization for Novel mHealth Solution
Health Advances worked with an early stage company with an innovative mobile patient engagement solution to prioritize potential applications and to develop strategies for product development and commercialization. The team recommended prioritizing medication adherence as an initial application and developed a strategy for winning in that vertical.
Patient Monitoring Strategy for Biopharma Company
Health Advances worked with a leading biotech company to develop a strategy for real-time monitoring of patients with a major chronic disease. The team thoroughly assessed existing biopharma initiatives in patient monitoring and identified critical success factors for development and adoption of these solutions. Based on this analysis, the team recommended several promising strategies for the client and built an execution plan.
mHealth Strategy for Biopharma Company
Health Advances worked with a leading global pharmaceutical company to develop mHealth strategies for their immunology franchise. The Health Advances team developed several novel product concepts in the areas of adherence management, disease management, and smart drug delivery for orals and injectables in rheumatoid arthritis, psoriasis, and lupus.
HIT Strategy in Continuous Glucose Monitoring
Health Advances developed the HIT strategy for a leading player in the continuous glucose monitoring (CGM) space. Based on a detailed assessment of market trends, unmet customer needs, and competitor development efforts, the team articulated a strategy emphasizing open-architecture data connectivity and built a detailed execution plan including a development roadmap, timeline, and budget.
Marketed Product Acquisition
Our client was in the process of transforming from an R&D company into a commercial organization in the cancer field when an attractive supportive care product became available as a result of a large company merger. We helped our client through two rounds of bids for the product, conducting due diligence, preparing valuation models, projecting the implications for the base business and infrastructure requirements, and developing the bid.
In-licensing Due Diligence
The business development team at a large pharmaceutical client engaged Health Advances to prepare a rapid turn around due diligence of a novel infectious disease product which they were considering licensing from a third party. Several other bidders were in the field; it was a novel approach to disease management and there was one major competitive threat. Our analysis recommended a valuation range.
Deal Strategy and Due Diligence
Health Advances conducted an extended acquisition-focused project with a small public biotech company seeking to complete a major acquisition. Over a period of several months, and in parallel with due-diligence level review of several possible candidates, Health Advances advised the management team on the criteria that it should use for evaluating the attractiveness and strategic fit. Health Advances continued to assist in the due diligence of various candidates that met those criteria until a deal was completed.
European Acquisition Candidate Search and Evaluation
Health Advances screened and reviewed OTC product and company acquisition opportunities in Europe for a major public pharmaceutical company. The project involved creating a database for capturing quantitative and qualitative information on a wide range of products and company product lines. Health Advances developed a set of criteria for screening the compounds, including such attributes as segment size and growth, product share and growth, competitive characteristics of the segment, fit with the client's skill sets and potential availability.
Biopharma: Diligence and Strategy for Achieving Coverage for Anemia Product in US and EU
Performed diligence on a novel anemia product by aligning with the client’s internal functions to develop a holistic view on the market opportunities and challenges for the asset in the US and EU5, and advise a path forward for achieving the most attractive coverage and pricing.
Biopharma: Preparedness for Access Risks for NASH Opportunity in the US, EU, and Japan
Generated detailed 10-year forecasts of the sizes of the NASH markets in the US, EU, and Japan. Leveraging Health Advances' deep expertise in global pricing and market access trends, the forecasts not only informed the client about the size of opportunity, but also to prepare for key access risks and opportunities.
Biopharma: Market Access Focused Design of Pivotal Trial for RNAi Therapy
Helped a leading RNAi therapeutic company to incorporate the perspective of key European HTA organizations in the design of their late stage pivotal trial. Casework included in-depth interviews with HTA experts, analog analysis, and a detailed review of HTA pathways, evidence requirements, and potential policy changes.
Biopharma: Product Value Position and Evidence Generation Strategy for Rare Disease Product in US and EU
Guided a biopharmaceutical company on how to prepare for commercialization of their lead product for an orphan disease in 7 markets, through product value proposition (PVP) development, PVP testing and validation, value-based pricing determination, and tactical market access plan and launch sequence creation.
Biopharma: Recommendation for Innovative Pricing Arrangements in US for Orphan Therapeutic
Helped a mid-size pharma company to understand drivers of US coverage and market access for its novel orphan therapeutic, including the likely adoption by US payers of specific innovative pricing arrangements.
Biopharma: US Price Recommendation for Mood Disorder Agent
Determined the optimal price that would allow for the target patient population access to the new agent, the access restrictions that would be imposed at the target price, and strategies to surmount these access restrictions.
Biopharma: US Pricing Potential for a Non-Orphan Gene Therapy
Considering the payer mix, the cost and clinical profiles of existing therapeutic alternatives, and potential tools payers could use to negotiate pricing and restrict access for a gene therapy delivered in the hospital, the team identified price points that would maximize access without sacrificing revenue.
Biopharma: European Recommendation of Orphan Drug Price
Delivered pricing recommendations for a novel orphan pediatric technology in seven European countries. Casework included quantitative analyses, analog price benchmarks, and comprehensive secondary and primary payer research.
Biopharma: Optimization of Price for Novel Orphan Product in Japan Under New Pricing Reform
During its search for a Japanese commercialization partner for a rare disease drug, Health Advances helped a European biotech understand how its drug would likely be analyzed by the Japanese pricing authorities and how recent updates to the system might affect the drug's price potential. Separately performed analysis of the Japan
Biopharma: Recommendation for Pan European Launch Sequence for Orphan Pediatric Therapeutic
Developed the market access launch sequence for a novel orphan pediatric therapeutic in 13 European countries. Deliverables included a custom-built dynamic tool to identify the revenue-optimizing launch sequence across key markets and multiple HTA scenarios and timelines.
Biopharma: European Market Access Launch Planning Tools for Osteoporosis Product
Amassed and triaged the critical internal and external market access activities and timelines for a large biopharma company seeking to introduce a novel biologic into the European market. Developed a market access launch tracking tool to facilitate work streams and alignment across Headquarters and affiliates for launch.
Biopharma: Global Burden of Illness and US Budget Impact for Novel Biologic
As part of an assignment to quantify the addressable patient opportunity for a small biotech company’s Phase 2 asset, developed global burden of illness and US budget impact models to demonstrate the value of its novel biologic to potential investors and partners and US payers. Presented at investor meetings and at _AMCP Nexus_.
Biopharma: US Cost of Illness Study for Orphan Disease
Quantified the benchmark cost of illness for an orphan disease through a robust quantitative analysis of longitudinal US administrative claims data, in-depth interviews with disease experts, caregivers and group home administrators. Study was published in _Journal of Pediatrics_.
Biopharma: US Payer Launch Engagement Strategy for Orphan Disease
Created a comprehensive payer launch engagement strategy for an orphan asset in Phase III development, including high-level timelines for engagement, strategic release of data and communication approaches, and a detailed database containing information on top influencers and payer organizations.
Medtech: Market Access Considerations for Global Product Expansion of Drug Delivery Device
Prioritized global expansion opportunities for a client’s drug delivery device. Systemically ranked and narrowed 60+ countries based on a multitude of factors, including size of patient population and impact of market access and pricing considerations on likelihood of success in each market.
Medtech: Pricing Recommendation for Novel Molecular Diagnostic in US and EU
Gained internal alignment on pricing for a novel molecular diagnostic system in the US and seven EU countries to determine current estimated costs, expert views of the novel system, value of savings associated with system adoption, acceptable costs, and impact of future changes in regulation and reimbursement.
Medtech: Orthobiologic Strategies for Distinct Coding and Differential Pricing
Created a reimbursement coding strategy for a novel orthobiologic to ensure a distinct HCPCS code, differential pricing, and market protection of Company’s product at launch.
Medtech: Demonstration of Value of Lymphedema Device Using Economic Evidence
Identified the limitations in the current economic evidence base for a launched medical device, proposed and executed a revised claims analysis, demonstrated statistically significant cost and resource reductions in high value patient subgroups, and armed our client with robust economic data to validate payer coverage.
Medtech: Access-Focused Commercialization Plan for Wound Product
Evaluated the impact of CMS reimbursement changes the client’s positioning, and segmented wound care practices to identify features correlated with lower barriers to using the new product. As a result, our client was able to develop targeted marketing messages and secure a partner with proper capabilities to maximize access.
Medtech: US Reimbursement Roadmap for Alzheimer’s Device
Provided a roadmap for a medical device company developing a new technology for Alzheimer’s to secure CPT coding and positive Medicare coverage and reimbursement in the US.
Medtech: Payer Facing Budget Impact Tool for GERD Device
Working for an implantable medical device company, Health Advances developed a budget impact model and break-even point for an approved procedure for managing gastroesophageal reflux disease (GERD). The team synthesized retrospective claims data, published clinical literature, and qualitative interviews with payers and clinicians and synthesized it into a payer-facing tool.
Remote Patient Monitoring Strategy
Health Advances worked with a company that had developed a novel solution for remote monitoring of critical care beds based on proprietary hardware and health IT. The team segmented the market, developed growth and positioning strategies for the company’s solution in each segment, and created a detailed implementation plan including development timelines and costs for new predictive algorithms.
HIT Growth Strategy for Medical Device Company
Health Advances helped a leading medical device company identify Health IT opportunities to deliver greater value to customers and accelerate growth. The team thoroughly assessed medtech company HIT activity to date, identified a wide range of potential HIT strategies for medtech, and developed several promising HIT opportunities specific to the client's current business and market position.
Laboratory Software Strategy for Diagnostics Company
Health Advances helped a leading in-vitro diagnostics company determine how to compete in the market for hospital laboratory software. The team identified a promising best-of-breed strategy that could succeed in the face of competition from enterprise solution vendors.
Hospital Workflow Software Due Diligence
Working with a medical device and software company, Health Advances performed commercial due diligence on a hospital-focused workflow optimization software solution for hospital radiology departments. The team validated demand, segmented potential customers, and identified promising growth avenues and strategies.
Clinical Trial Software Due Diligence
Health Advances conducted commercial due diligence on a company competing in the “eClinical” software market, which consists of solutions for key aspects of clinical trials, including electronic data capture, patient-reported outcomes, and site management. The team developed a strategic view of the future market and recommended segmentation and positioning strategies.
Long-Term Care Software Due Diligence
Health Advances conducted due diligence on a company competing in the market for clinical information systems for long term care facilities. Based on extensive primary research with nursing home administrators and industry experts, the team assessed the competitive position and growth potential of the target company.
Adherence Solution Due Diligence for Biopharma Company
Working with a major multinational biopharma company, Health Advances conducted due diligence on two adherence technologies under consideration for partnership or acquisition. For each technology, the team assessed potential clinical and economic impact and performed a valuation analysis to help the client secure fair pricing for the deals.
Quantifying the Value Proposition of a Software Solution for Hospitals
Working with the vendor of a software system designed to detect and help prevent hospital acquired infections, Health Advances analyzed and quantified the clinical and economic value created by this solution in order to help the company drive adoption. This analysis formed the basis of a dynamic economics model that could be used by company field reps to quantify economic ROI for prospective customers.
National Patient Registry Strategy for Disease Organization
Health Advances worked with a national disease organization to develop a strategy to optimize the organization’s national patient registry and to maximize its value to researchers, administrators, clinicians, and patients. Recommendations included detailed changes to the registry’s structure, user-interface, governance, and business model.
National Patient Registry Strategy for Disease Organization
Health Advances worked with a national disease organization to develop a strategy to optimize the organization’s national patient registry and to maximize its value to researchers, administrators, clinicians, and patients. Recommendations included detailed changes to the registry’s structure, user-interface, governance, and business model.
Meaningful Use Software Evaluation
Working on behalf of a potential acquirer, Health Advances evaluated a best-of breed software system designed to assist hospitals address meaningful use criteria. The team assessed growth opportunities and forecasted market potential by hospital segment based on their current EMR system.
Pre-Launch Commercial Strategy for Orphan Disease
To support the pre-launch commercialization planning for a global pharmaceutical client’s novel orphan drug, Health Advances examined pre-launch marketing activities across a variety of orphan, specialty, and primary care drugs. Pre-launch activities geared towards various stakeholders including disease awareness and education campaigns, clinician outreach, conference and continuing medical education strategies, and patient advocacy support and events were evaluated to determine relative impact on downstream drug adoption. Interviews were conducted with clinicians, patients, payers, and patient advocacy representatives.
Launch Preparation for Oncology Agent
Health Advances supported a large biotechnology company with preparation for the launch of a new targeted oncology agent. The commercial team needed to understand the impact that a short stability window could have on product adoption and develop plans accordingly. The team conducted interviews with pharmacists, oncologists, and oncology nurses to understand the current workflow, issues related to wastage, and cost. Specific case studies were used to highlight key issues and potential solutions to avoid any negative impact on adoption.
Launch Strategy for Schizophrenia Drug-Diagnostic
Health Advances was engaged by a leading biotechnology company to aid in the development of a launch strategy for a drug-diagnostic combination for schizophrenia. Health Advances mapped the current diagnostic paradigm, use of pharmaco-genomic testing, and barriers to use. Using analogs, the team identified relevant strategies to drive adoption and developed an action plan for the client to execute for a successful launch.
Strategic Imperatives and Launch Roadmap
An international pharmaceutical client asked Health Advances to support the launch of its first product into a new North American geography. Health Advances reviewed and consolidated all internal research and brand strategies to identify key market insights and knowledge gaps. The team utilized these market insights to develop brand strategic imperatives to guide the product launch. Health Advances then facilitated a one-day workshop with the company to synthesize, validate, and enhance the brand strategic imperatives. The team also developed fit-for-purpose launch planning templates that reflected the brand strategic imperatives. Health Advances worked with each functional group to synthesize launch roadmaps that outlined ownership, dependencies, timing, opportunities, challenges, risks, and mitigation plans for all launch-related activities.
Lifecycle Management for Marketed Biologic
To develop a lifecycle management strategy for a marketed biologic drug, Health Advances integrated compelling commercial and clinical assessments to justify an investment case for senior management of a large biopharmaceutical company. In a rigorous data-driven process, 25 potential indications were evaluated in successive stages using a combination of primary and secondary research to arrive at a single prioritized indication with the optimal combination of strategic fit, commercial potential, and clinical feasibility. A leading CRO in the critical care space was engaged to provide detailed cost estimates for the clinical development program. Detailed trial protocols and inclusion/exclusion criteria were developed. A robust, scenario-based and risk-adjusted forecast model and NPV analysis was developed. The team outlined actionable recommendations for risk mitigation and staged investment.
Lifecycle Strategy for Phase III Oncology Drug
Health Advances completed a lifecycle management project to plan the next set of indications for a Phase III oncology compound across the US, Europe and Japan. An extensive KOL physician interview program was performed to narrow over 20 opportunities to a handful of high priority initiatives for review with senior management. Health Advances also participated in the design and analysis of a quantitative physician survey and EU payer study, and worked closely with the internal client team to develop revenue forecasts and sensitivity analyses.
Lifecycle Initiatives for Late-Stage MS Therapy
Health Advances analyzed the commercial opportunities associated with key potential lifecycle initiatives for a late-stage MS therapy with properties suggestive of broader applicability across immunologic and neurologic diseases. The analysis included evaluating the market potential, pricing and reimbursement potential, and support of the product's key positioning across a number of MS focused and orphan disease focused initiatives. Health Advances performed extensive qualitative research within the United States and Europe, encompassing MS KOLs, experts in orphan diseases, and key payers and regulatory consultants. The team provided key commercial insights and strategic recommendations to the program team as part of the overall lifecycle management plan.
Lifecycle Management in Pulmonology
Our client had a marketed drug for a narrow pulmonology indication and asked Health Advances to evaluate additional opportunities ranging from orphan indications to diseases affecting millions of patients. Health Advances screened several dozen applications for scientific evidence, relevance to disease mechanism, ease of development, and commercial potential, in order to narrow in on a small number of opportunities. Special attention was given to route-of-administration/formulation requirements for the different applications and the cost and timeline of development in each.
New Indications for an Orphan Disease Drug
As part of a lifecycle management strategy for a recombinant protein in late stage development for an orphan indication, the team integrated compelling commercial and clinical assessments to justify an investment case for senior management of a large biopharmaceutical company. In a rigorous data-driven process, over 30 potential indications were evaluated using detailed primary and secondary research to arrive at two prioritized indications. These prioritized indications were evaluated more deeply to provide a top-level clinical development plan and visibility into revenue potential. Requirements for topical reformulation were also evaluated for specific indications. Throughout the project, interviews were conducted with top thought leaders to inform the team's comprehensive market assessment and clinical literature review. This work was presented to the client's upper management in research and development.
Health Advances worked closely with the brand management team of a client organization to evaluate the market potential of a novel reformulation of a marketed oncology drug, and provided strategic guidance for its positioning and launch strategy. Through a rigorous primary research program focused on US- and EU-based community physicians and key opinion leaders, patients, and payers, the team assessed the adoption potential, target patient segments, and examined the clinical development requirements. The team also examined the reimbursement and pricing landscape to inform the launch strategy both in the US and EU.
Assessment of Market Potential and Resource Requirements
Health Advances prepared a complete market opportunity assessment and preliminary commercialization plan for an innovative product used for treating chronic pain. Extensive interviews with pain specialists, surgeons, internal medicine physicians and other providers, interviews with reimbursement specialists, and a comprehensive competitive analysis all contributed to an integrated analysis of how the product would be positioned, its forecasted market potential, and the resources that would be required to drive market penetration.
Market Analysis and Risk-Adjusted Financial Forecast
A Health Advances team provided a detailed market analysis and product concept refinement for a novel, non-protease inhibitor for management of HIV patients. The team spoke with many of the leading viral disease specialists in the US, Europe, and Japan to map current disease management practices, estimated potential patient populations, determine dosing and pricing estimates, and identify red flags in the product concept for each of the different geographies. In addition, the Health Advances team developed profiles of the relevant competitors and potential partners, and forecasted potential costs and revenues in a risk-adjusted NPV model.
Market Segmentation and Revenue Forecast
A client with a novel diabetes treatment in the midst of licensing negotiations engaged Health Advances to develop a detailed revenue forecast and product positioning strategy. This novel therapeutic was targeted at the Type 2 market, but would require a subcutaneous or intramuscular injection, potentially creating significant barriers to adoption. The Health Advances team spent a significant amount of time mapping distinct patient populations that would consider this therapeutic option.
Revenue Forecast with Sensitivity Analysis
The Health Advances team prepared a detailed five-year US revenue projection for a phase III oncology drug, including projections for uptake of the drug for various lines of therapy: from salvage to first-line and monotherapy versus combination therapy. The analysis included building a revenue model using inputs from qualitative in-depth interviews followed by a large quantitative survey. Health Advances completed statistical analysis of the quantitative survey and performed sensitivity analyses on the revenue projections for a number of potential factors that could influence the uptake of the drug, including what labeling would be approved and whether there would be a black box warning required on the label.
Assessment of Likely Adoption using Patient Survey
For an Israeli company moving into the US market, Health Advances developed and administered a large survey of people with a particular vision problem, seeking volunteers for clinical trials to assess the treatment's effect. Health Advances identified, screened and surveyed over 45 patients regarding their likelihood to try the new treatment for their vision problem. Health Advances documented patients' level of satisfaction/dissatisfaction with past or current treatments, the degree to which the vision problem impacted their daily lives and their likelihood to pay out-of-pocket for this novel treatment.
Assessment of Market Potential
Health Advances assessed the market for cord blood banking for a private equity company considering acquisitions and/or roll up in this area. Primary work streams included a detailed evaluation of the present and future scientific and clinical backing for this industry, based on KOL interviews and secondary research; qualitative physician (OB) and patient interviews to evaluate attitudes towards and demand for the product; and a quantitative physician survey to test and refine hypotheses generated by the qualitative interviews.
Health Advances completed a choice-based conjoint study, complemented by a Van Westendorp analysis, to assist a client with several critical strategic decisions, including what business model to use to maximize revenues for a novel device-based treatment for severe acne, what type(s) of physicians besides dermatologists might be interested in participating in this business model and treating severe acne patients, as well as how to price the product or service to maximize revenues. The conjoint study surveyed both a variety of physicians and patients.
A client with a product entering Phase II sought our assistance in identifying and qualifying a small number of companies to approach for licensing discussions. Using secondary information and conversations with target companies we were able develop a short list of targets and a suggested approach to each company.
In-licensing Opportunity Identification
Health Advances was engaged by a large biotech company to help identify in-licensing opportunities in the pain control field. After working with the client to develop a set of criteria and define the field, we prepared a comprehensive screen of potential opportunities in the US and Europe. The Health Advances team spent considerable time with management reviewing the opportunities and finalizing a target list for the company's business development team to pursue.
Out-licensing BD Support:
Alongside a one-person BD function with multiple products to out-license, Health Advances worked with our client to develop a comprehensive out-licensing package for a Phase II product. We prepared the valuation model, developed confidential and non-confidential materials, developed a prioritized list of companies, and supported the BD person throughout the negotiations.
Identifying and Evaluating In-Licensing Candidates
A client that had completed its public offering sought our assistance in identifying and assessing potential in-licensing candidates. Recognizing the impatience of public investors, the company sought specific products that it could pursue to supplement the existing pipeline of early-stage, novel chemotherapeutic agents. Health Advances worked closely with the client to develop a list of key criteria, which our team then used to identify, screen and prioritize potential in-licensing candidates for the client.
Health Advances was brought in by the new CEO of an early stage pharmaceutical company to help optimize the company's R&D portfolio. The company was focused on treatments for genetic diseases. Health Advances screened over 100 genetic diseases on the basis of technical and commercial criteria to prioritize the company's portfolio and create a clinical development plan to generate maximum value. The project also included an analysis of the company's operational capabilities that identified the human and capital resources needed to execute the portfolio strategy.
Evaluation and Prioritization of Market Opportunities
Health Advances assessed the market opportunities for a device/drug combination in the area of atherosclerosis. Health Advances screened over 4,500 drugs in development for potential applications in the identified areas of unmet need for atherosclerosis. This information was incorporated into a 20-year strategy plan for a large, public healthcare company, based on the above opportunities down to a drug level.
Screening and Prioritization of Target Indications to Drive R&D Strategy
A foreign client had historically pursued the antimicrobial coating applications of its novel silver technology. Recently, however, the company gained confidence, through anecdotal evidence and in vitro studies, that the same technology could be employed as a pharmaceutical. In order to focus the necessary research and development, Health Advances was hired to help screen potential pharmaceutical applications for the technology. Health Advances evaluated a wide range of indications where the client believed it could add the most value, from respiratory to orthopedic to cardiac and more clinical areas. Subsequent phases of the work delved more deeply into the areas highlighted as promising in this initial screen and further prioritized specific indications, forming the basis for the company's R&D strategy.
Identification, Evaluation and Prioritization of Target Drugs for a Drug Delivery Company
Health Advances evaluated and prioritized over 200 injectible generic drugs for a mid-tier public drug delivery company with a desire to begin developing drugs for its proprietary portfolio rather than solely with branded partners. The list of candidates was evaluated against several criteria including the value-based premium that a sustained release version of each drug could warrant, the technical applicability of technology to each drug versus competitive sustained release technologies, and the future market dynamics in light of current and future branded drug classes for the same indication(s).
Portfolio and Franchise Strategy
Health Advances identified, screened and developed innovative initiatives to support a large biotech company's major disease franchise strategy. Activities included extensive internal company interviews, on-site clinic observations, in-person patient and physician interviews, in-depth KOL phone interviews, and an online specialist survey. Financial analysis focused on calculating return-on-investment for each potential initiative.
In-line Product Franchise Strategy
Health Advances orchestrated a comprehensive strategy development process for the US division of a major pharmaceutical company. Involving the entire management team, the process involved looking at the strengths and weaknesses of the in-line product
Refining the Product Positioning for a New Market Entrant
Obesity products, such as Xenical, have not been as successful as many expected largely due to side effects and modest efficacy. To solidify the product position for a new market entry, Health Advances conducted physician and patient interviews to understand current usage patterns, the importance of dietary management and other supportive management techniques to complement drug therapy, and the implications for the market potential, competitive positioning and promotion of this new agent.
Product Positioning for a Novel Cancer Therapy
Health Advances assisted a client in Phase I development of a novel cancer therapy in preparing for its later phase clinical trials and discussions with potential commercial partners. The Health Advances team undertook a thorough analysis of the way that the product would likely be used in the clinic. This research included the product's positioning relative to existing therapies and future therapies, physician reaction to the efficacy and side effect profile, as well as pricing and dosage regimen. Based on these insights, Health Advances defined the target population, refined the product profile appropriate for the target segment and refined the draft of the desired label claims.
Therapeutic Device Positioning
Health Advances studied the market for a currently marketed therapeutic medical device for prostate cancer to determine how to achieve broader market penetration. The team evaluated pros and cons of positioning the product as a first-line alternative treatment versus a second-line therapy for treatment failures. The study involved interviewing both current users and non-users to determine current perceptions of product positioning and use, and assessed the opportunity for growth and the likely requirements for penetration (clinical trials, etc.) in other indications not yet targeted by the client.
Diagnostic Imaging Software Product Positioning
For a small, private company, Health Advances assisted with positioning a software product for interpreting MRI used in breast and prostate cancer for market launch. The research involved assessing which patient segments within each indication would have the most economic and clinical value. In breast cancer, the team looked at the initial diagnosis of high-risk patients versus use as a second line diagnostic tool for suspicious mammography versus post-surgical follow up.
Therapeutic Device Product Positioning Strategy
Health Advances was engaged to assess the optimal positioning of a client's laser versus competitive products, including drugs and other device-based dermatological treatments. The client's laser was already marketed, but had a new indication that Health Advances was investigating. As a part of this study, Health Advances conducted a conjoint analysis study with consumers and physicians to develop a positioning strategy.
Retrospective Longitudinal Study of the Health Economics of Preventing Post-Surgical Adhesions
Using actual claims data from a private insurer, Health Advances quantified the incidence and costs related to the diagnosis and treatment of an important post-surgical complication. From this analysis, the value to payers, hospitals and physicians was quantified. Finally, a demand curve was developed looking at the value by type of precipitating surgery and patient demographics versus the number of individuals in that segment. This facilitated the identification of the revenue-maximizing price point for this product, from a purely cost-effectiveness perspective. At the request of the client, Health Advances drafted a manuscript of this groundbreaking work for publication. Currently the client is seeking a clinician to serve as a co-author to the study.
Assessment of the Clinical Need and Top-level Economics of Infection Prevention for Dialysis
Catheters and other Dialysis Devices and Equipment: As part of a large project identifying and evaluating clinical need and market potential for antimicrobial coatings on a broad range of medical devices, Health Advances conducted primary and secondary research on devices used for dialysis patients, including catheters and dialyzing equipment. Analysis included quantifying the incidence of infection in dialysis patients and gaining an understanding of the source and cause of infection to assess the feasibility of applying a proprietary antimicrobial coating technology to some or all of the devices used on dialysis patients.
Documentation of the Clinical Pathways and Analysis of a Physician's Research Database to Develop a System Economics Basis for FDA Approval and Market Pricing
Health Advances identified and analyzed a large research database developed by a leading orthopedic surgeon to assess the frequency of different corrective procedures for damaged knee cartilage and their outcomes. Quantitative and qualitative measures of outcomes were captured, including timing to subsequent treatments. This information was combined with primary interviews with orthopedic surgeons to document the current clinical pathways by patient segment. The Health Advances team also quantified the economics of a novel therapeutic procedure, assuming a range of success rates as experienced in clinical trials. This work was included in the BLA filed with the FDA and, subsequently, approval was granted.
Quantification of the Health Economics for Various Constituencies
By mapping out the current diagnostic pathway for detection of palpable versus non-palpable breast cancer, and overlaying the reimbursement levels for each node in the pathway with reimbursement to the facility, doctor and/or lab, Health Advances quantified the value of substituting the novel diagnostic test at each node vs. current protocol. This resulted in identifying the revenue-maximizing point in the diagnostic work-up at which to position this device. Health Advances also documented the key decision makers for each type of test and, hence, understood who would be "gainers" versus "losers" from the clinician's perspective by replacing a current method with this new device. Finally, because assumptions for sensitivity and specificity of the new device were implicit in the economic calculation, the cost effectiveness model allowed the client to quantify the economic impact of various sensitivity/specificity tradeoffs to optimize revenues. Subsequently, Health Advances conducted follow-on work to quantify the economics for the device in several major European markets and in Japan.
Study of the European Clinical and Reimbursement Practices
Health Advances researched the clinical practice patterns and reimbursement practices and rates for eight European countries with respect to home hemodialysis. The study included primary interviews with physicians in each country to understand similarities and differences in practice patterns for treating dialysis patients and drivers of those practice patterns in each country.
Commercial Strategy Development
A small public biotech company previously focused on drug discovery and development sought Health Advances' help to develop a strategy to build a more fully integrated organization. We helped prepare a comprehensive plan that included a reprioritized product portfolio, a detailed in-licensing and out-licensing plan, an infrastructure plan, and pro-forma financials to guide the transition and assemble a sales and marketing organization.
Biotech Transformation Strategy
Working directly with the new CEO, Health Advances led a planning process to lay out a multi-year plan for transforming the company from a platform company into a product company. The plan completely changed the vision and business model, requiring an extensive examination of how a product portfolio would be created and the organizational skills that would be required.
Drug Company Division Spin-out
As a result of a corporate restructuring, a decision was made to spinout a large division as a separate company. Health Advances worked with the management team to design the new strategy for the company including the prioritization of product lines, geographic markets, and the development pipeline.
Working with the corporate executive team of a multi-billion dollar healthcare company, Health Advances led a board-mandated review of the strategic positioning and business options for two divisions within the company. In addition to a thorough assessment of internal strengths and weaknesses, we also examined the competitive environment, trends with customers, our clients' position, and the options for expanding the business internally and through acquisition.
The client management team wanted to develop a strategy that would dramatically enhance the momentum for the company. By reviewing the technology platform and portfolio, the organizational strengths, and opportunities to apply those in new areas, we identified several new strategic directions for the company and developed detailed plans for building internal skills capabilities and driving business development activities.
Health Advances was brought in by the new CEO of an early-stage pharmaceutical company to help optimize the company's R&D portfolio. The company was focused on treatments for genetic diseases. Health Advances screened over 100 genetic diseases on the basis of technical and commercial criteria to prioritize the company's portfolio and create a clinical development plan to generate maximum value. The project also included an analysis of the company's operational capabilities that identified the human and capital resources needed to execute the portfolio strategy.
Health Advances was asked to provide a detailed market analysis and product concept refinement for two early-stage next-generation supportive-care oncology products. Health Advances spoke with hematologists and medical oncologists in US, Europe, and Japan to map current treatment pathways for chemotherapy and bone marrow/stem cell transplant patients, estimate potential patient populations, determine dosing and pricing estimates, and identify red flags in the product concepts for each of the different geographies. Once the market was sufficiently characterized, Health Advances used this knowledge to forecast the products' potential costs and revenues. Health Advances used this information to drive a Monte Carlo analysis and generate a risk-adjusted NPV model.
A leading venture capital firm was considering an investment in a private company that was developing a novel controlled-release drug delivery system with applicability across a number of therapeutic areas. Health Advances was asked to evaluate the commercial potential of the company's later-stage products as part of the due diligence process. Using primary and secondary research, Health Advances analyzed the potential value created by these products, assessed the company's clinical trials, and characterized the competitive landscape.
We developed a complete commercialization strategy for a novel chemotherapeutic agent starting with analysis of the indications, product positioning, and market potential and leading through the clinical trial plan and finishing with the partnership strategy.
With a significant investment in the siRNA field, our client faced the challenging question of which of the many possible indications to move into development. We agreed on which indications would lead to a clearly differentiated product profile and determined which other applications to partner or to hold on to for future development.
Crohn's and Ulcerative Colitis
With a large number of compounds in the pipeline, our client was facing a challenging question regarding the proper focus and development path for a new mechanistic approach involving the th1 and th2 immune response. Combining commercial and competitive issues with an assessment of the development hurdles, we were able help the client finalize a set of development priorities and confirm the investment required to complete development of their compound.
Health Advances was asked to provide a detailed market analysis and product concept refinement for two early-stage, next-generation, and supportive-care oncology products. The Health Advances team spoke with hematologists and medical oncologists in the US, Europe, and Japan to map current treatment pathways for chemotherapy and bone marrow/stem cell transplant patients, estimated potential patient populations, determined dosing and pricing estimates, and identified red flags in the product concepts for each of the different geographies. Once the market was sufficiently characterized, Health Advances used this knowledge to forecast the products' potential costs and revenues. Health Advances used this information to drive a Monte Carlo analysis and generate a risk-adjusted NPV model.
A small biotech company was in the process of licensing a hand-held device to count white blood cells. Health Advances was hired to help the client quantify the device's market potential for the purpose of negotiating the most favorable deal terms. Health Advances interviewed oncologists and infectious disease specialists to map out the current treatment pathway and identified the patient population in which this cell-monitoring device would create a clinical benefit, as well as cost benefit. Health Advances projected pricing by evaluating system economic factors, as well as analog products and current therapies. The client used Health Advances' market sizing estimates to assist in their negotiations with the licensor.
Financial Modeling of Synergy Potential for an Acquisition Target
A private equity firm engaged Health Advances to evaluate a potential investment in a specialty generics company, focused on the treatment of hepatitis C that used the specialty pharmacy channel as the main outlet for its products. As part of the analysis, Health Advances examined the potential synergy of combining the company's existing business with an in-process acquisition. Using a series of physician and industry interviews, combined with extensive secondary research, Health Advances identified several key areas of instability within the target company's base business, and quantified the upside and downside scenarios for this business in it current state. These insights, supported by a strong fact basis, tempered the client's enthusiasm for the target's current value but Health Advances developed a strategically focused opportunity screen to identify potential candidates to add scale to the base business sufficient to leverage the proposed salesforce and create more value.
Outsourced Business Development Support
Health Advances directed the business development effort leading to the sale of a medical device company. Involved from the earliest stages of the decision to seek a partner or exit strategy, Health Advances valued the company portfolio, prepared the road show presentation, identified target companies, approached the companies to investigate their interest, conducted due diligence on several companies, and supported the final negotiations.
Valuation of a Novel Cardiopulmonary Bypass Oxygenator
For a strategic buyer, Health Advances forecasted the revenues of an improved oxygenator that appeared to reduce the peripheral damage caused by traditional cardiopulmonary bypass circuits during major cardiothoracic procedures. In addition to estimating future penetration of the market, the study also sought to forecast the future volumes of these procedures in light of changing demographics and inroads of interventional procedures.